Disinfectant composition for control of clostridium difficile spore

ABSTRACT

A composition and method for inducing and inflicting damage to cell membranes of microorganism by inducing changes in membrane permeability caused by polycation-induced membrane pores. The control of Clostridium difficile spores with an efficacy of 99.99% on hard surfaces is provided. The invention includes the application of an evaporation-induced self-assembly, surfactant-mediated synthesis or self-condensing polymer, which forms a film which is both flexible on the surface as a nano-polymeric coating and with refractive index yielding a transparent coating. The polymeric matrix includes various biocidal polymeric cationic quaternary salts, one being a silyl quaternary having a kinetic zeta potential to disrupt bacterial spores functions. The polymeric matrix consist of multiple small molecule biocides as well as polymerics biocide combinations not otherwise seen to develop an surface topography of peaks and troughs in the nano range to resist bacterial adhesion factors and subsequent biofilm formation. The surfactants induce self-assembly film topography.

This application claims the priority benefit under 35 U.S.C. section 119of U.S. Provisional Patent Application No. 62/547,844 entitled“Disinfectant Composition For Control Of Clostridium Difficile Spore”filed on Aug. 20, 2017; and which is in its entirety herein incorporatedby reference.

FIELD OF THE INVENTION

The bacteria Paenibacillus polymyxa produces the antibiotic colistin orPolymixin E. Colistin is the strongest antibiotic by nature and the oneof last resort, as it can damage the kidneys and nerves. The WorldHealth Organization and the Center for Disease Control unfortunatelyhave confirmed superbugs resistant to Colistin. Colistin is apolycationic peptide C₅₂H₉₈N₁₆O₁₃ with a molecular mass of 1155 gm/mol.Colistin's cationic regions interact with the bacterial outer membraneby displacing magnesium and calcium, the bacterial counter ions in thelipopolysaccharide.

In addition to superbugs, the incidents of bacterial spore outbreakssuch as Clostridium difficile continues to increase in hospitals andadult care centers. Spores are extremely difficult to destroy withnon-hazardous chemicals.

To counter the diversity of spores and superbugs in a hospitalenvironment or workplaces, a mixture or cocktail of antimicrobials is analternative to treat surfaces. Microorganisms are ubiquitous within theworkplace structure, from ceiling to floor, from walls to doors, and anyequipment or persons therein. A safe low dosage mixture of compoundswhich does not destroy or corrode equipment, metal, plastic, textiles orelectronics is sorely needed. A safe low dosage mixture of compoundswhich adheres to the hard or porous surfaces for extended time and isefficacious is sorely needed in the anti-infective field.

The present invention utilizes a mixture of cationic biocides andnon-ionic surfactants that includes a condensation polymer of poly1-Octadecanaminium NN Dimethyl N (3 Trihydroxysilyl) propyl chloride asthe base film on substrates and further binds it to substrates incombination with its monomer 1-Octadecanaminium NN Dimethyl N(3-Trimethoxylsilyl) propyl chloride or 1-Octadecanaminium NN Dimethyl N(3-Triethoxylsilyl) propyl chloride or 1-Dodecanaminium N,N Dimethyl N(3-Trimethoxylsilyl) propyl chloride and 1,2-Bis(Triethoxysilyl) ethaneto form a self-assembled evaporative nano cationic architectural film.The trihydroxy, trimethoxy and triethoxy groups are the functionalgroups that adhere to substrates encasing the substrates like a glove.

BACKGROUND OF THE INVENTION

In the United States compounds used to disrupt, mitigate, kill orprevent microorganisms in the environment (other than on or in animalsor humans) are regulated by the Environmental Protection Agency EPAunder the “FIFRA” act. The EPA listing of chemistries includes Calciumand Sodium Hypochlorite, peroxides, heavy metals namely Zinc, Silver andCopper, Quaternary ammonium salts, Gluteraldehyde, Formaldehyde andIsothiozolinones, Dithiocarbamates, Methylene-bis thiocyanate andethylene oxide gas.

In U.S. Pat. No. 5,814,591 Mills et al states that the use of EDTA and aquaternary ammonium salt with surfactant can remove soil and be a hardsurface disinfectant. Mills does not teach of persistent film formers onthe surfaces.

In U.S. Pat. No. 6,994,890 Ohlhausen et al reveal the use of anorganosilane quaternary compound and hydrogen peroxide in a cleaning andmultifunctional coating composition. No mention of effecting spores isdiscussed.

In US 2006/0193816 A Elfersey teaches the use of a mixture of silanequaternary ammonium monomers to form a film on a hard surface or textileto effect bacteria. He combines the formulation with alkyl dimethylbenzyl quaternary ammonium salt and hydrogen peroxide. He does addPolyhexanide (polyhexamethylene biguanide, PHMB) which is instantlyeffective on Pseudomonas aeruginosa but does not define any formulationto affect the architecture of the surface as to increase adhesion of thepolymer or remove any of bacteria or deplete biofilms.

In US 2010/0279906 Schwarz describes an antimicrobial compositionconsisting of mixed quaternary ammonium compounds mixed with silanefluids. He does not discuss the silane quaternary ammonium salts.

In US 2014/0011766 Krafft teaches a 1.5% active organosilane in ethanolas being a hard surface disinfectant. Krafft doesn't mention theflammability of a 50% ethanol hard surface disinfectant in comparison toa water based non-flammable product. Kraft doesn't teach that theproduct can be nearly alcohol free (<1.0%) and be efficacious.

In US 2017/0166755 Moros et al describe the making of an organosilaneand electrostatically spraying onto surfaces, allowing to dry, followedby electrostatically spraying peroxo-titanium acid solution with aperoxide modified anatase solution as an overspray to preventmicroorganism growth on surfaces in a hospital setting. Moros doesn'tteach that it can be used for as a cleaning aid to reduce microbes or onwipes to disinfect hard surfaces.

SUMMARY OF THE INVENTION

The invention provides an antibacterial and antiviral composition forinducing and inflicting damage to cell membranes of said infectiousmicroorganism by inducing changes in membrane permeability, saidcomposition comprising effective amounts of a quaternary ammoniumpolymeric film former; a coupling agent; one or more antimicrobialpolymeric macromolecules; one or more antiviral polymericmacromolecules; an antimicrobial small molecule; one or more surfactantsfor micellular dispersions and self assembly properties; a chelatingagent, a preservative and optionally a fragrance.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates the structure of a clay stabilizer that shows thatwater trapped within the clay matrix provides for a water bridge for thetrihydroxysilyl stability and freeze point reduction.

DETAILED DESCRIPTION OF THE INVENTION

Bacteria survive most disinfectants more so when the bacteria aresheltered within a biofilm. During this time bacteria survive and arecompetent which defines a cannibalistic state of consuming parts (DNA)of other bacteria. It is here that horizontal gene transfer can occur.This is the theory of evolving and becoming resistant to disinfectantsand antibiotics. Recently Enterococcus faecisum has become resistant toisopropanol and Burkholderia cepacia has grown in antimicrobials withBenzalkonium chloride and Chlorhexidine gluconate 2%. There is a longfelt need to have more diverse systems of 3 or more actives to counterbacterial resistance as well as non migratory polymeric antimicrobialactives.

The invention provides compositions that include one or more of thefollowings:

i) an alkoxy silyl ammonium compound monomer,

ii) an alkoxy silyl ammonium compound polymer,

iii) an advanced 1,2-Bis(Triethoxysilyl) ethane coupling agent,

iii) a polymeric biguanide; and

iv) a polymeric stabilizer such as a smectite, bentonite or filler suchas hydroxyethyl cellulose or other hydroxyalkyl celluloses.

In some embodiments, the alkoxy silyl ammonium polymer and monomercombination film-forming agents is an alkoxy silyl quaternary ammoniumfilm forming agent. Alkoxy silyl quaternary ammonium film forming agentsare also known in the art as organosilicon quaternary ammonium filmforming compounds.

In some embodiments, the alkoxy silyl ammonium film-forming agent is acompound of formula.

Other film forming agents include compounds corresponding to thefollowing formula R₁,R₂,R₃—Si—CH₂CH₂CH₂—N⁺—R_(Y)R_(X)R_(Z) W⁻ wherein W⁻is a Cl, Br; F or I, more in particular Cl⁻ R₁,R₂,R₃ are CH₃O or CH₃CH₂Ogroups. In particular embodiments, one or more of the following may besuitable R₁,R₂,R₃ are a hydrogen, hydroxy, alkoxy such as methoxy orethoxy, alkyl such as methyl or ethyl; R_(Y) is a C₁-C₅ alkyl grouppreferably a CH₃ group; and R_(X) is C₁-C₅ alkyl group preferably a CH₃group; and R_(Z) is a C₇-C₁₈ alkyl or a mixture of various alkyl speciesbut predominately C₁₈ alkyl or C₁₂ alkyl or both, more particularly C₁₈alkyl.

In particular embodiments, the alkoxy silyl ammonium film-formingcompound of formula (I) is selected from the group consisting of:1-octadecanaminium-N,N-dimethyl-N-[3-trimethoxysilyl(propyl)]chloride,3-trimethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride),3-triethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride,3-trimethoxysilyl propyl-N,N-dimethyl-N-octyl ammonium chloride,3-triethoxysilylpropyl-N,N-dimethyl-N-octyl ammonium chloride,3-triethoxysilylpropyl-N,N-dimethyl-N-isodecyl ammonium chloride,3-trimethoxysilylpropyl-N,N-dimethyl-N-isodecyl ammonium chloride,3-trimethyoxysilyl-propyl-N,N-dimethyl-N-decyl ammonium chloride,3-triethyloxysilylpropyl-N,N-dimethyl-N-decyl ammonium chloride,3-trimethyoxysilylpropyl-N,N-dimethyl-N-dodecyl ammonium chloride,3-triethyloxysilylpropyl-N,N-dimethyl-N-dodecyl ammonium chloride,3-trimethoxy-silylpropyl-N,N-dimethyl-N-tetradecyl ammonium chloride,3-triethoxysilylpropyl-N,N-di-methyl-N-tetradecyl ammonium chloride,3-trimethoxysilylpropyl-N,N-dimethyl-N-hexadecyl ammonium chloride,3-triethoxysilylpropyl-N,N-dimethyl-N-hexadecyl ammonium chloride,3-trimethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride,3-triethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride,3-trimethoxysilylpropyl-N,N-dimethyl-N-docosyl ammonium chloride,3-triethoxysilylpropyl-N,N-dimethyl-N-docosyl ammonium chloride,3-trimethoxysilylpropyl-N,N-dimethyl-N-eicosyl ammonium chloride,3-triethoxysilyl-propyl-N,N-dimethyl-N-eicosyl ammonium chloride,3-trimethoxysilylpropyl-N,N-dimethyl-N—C₁₂-C₁₆ ammonium chloride, whereC₁₂=65% and C₁₆=33%, 3-triethoxysilylpropyl-N,N-dimethyl-N—C₁₂-C₁₆ammonium chloride, where C₁₂=65% and C₁₆=33%,3-trimethoxy-silylpropyl-N,N-dimethyl-N—C₁₆-C₂₂ ammonium chloride, whereC₁₆=16% and C₂₂=83%, 3-triethoxysilylpropyl-N,N-dimethyl-N—C₁₆-C₂₂ammonium chloride, where C₁₆=16% and C₂₂=83%,3-trimethoxysilylpropyl-N,N-dimethyl-N—C₁₄-C₁₈ ammonium chloride, whereC₁₄=4%, C₁₆=31% and C₁₈=64%,3-triethoxysilylpropyl-N,N-dimethyl-N—C₁₄-C₁₈ ammonium chloride, whereC₁₄=4%, C₁₆=31% and C₁₈=64%,3-trimethoxysilylpropyl-N,N-dimethyl-N—C₁₂-C₁₆ ammonium chloride, whereC₁₂=41%, C₁₄=50% and C₁₆=9%,3-triethoxysilylpropyl-N,N-dimethyl-N—C₁₂-C₁₆ ammonium chloride, whereC₁₂=41%, C₁₄=50% and C₁₆=9%,3-tri-methoxysilylpropyl-N,N-dimethyl-N—C₁₂-C₁₈ ammonium chloride, whereC₁₂=49%, C₁₄=20%, C₁₆=11% and C₁₈=10%, and3-triethoxysilylpropyl-N,N-dimethyl-N—C₁₂-C₁₈ ammonium chloride*, whereC₁₂=49%, C₁₄=20%, C₁₆=11% and C₁₈=10%.

The alkoxy silyl ammonium film-forming compound is present in thecomposition in an amount in the range of 0.1% to 5.0% w/w, especiallyabout 1.0% to 3.0% w/w, more especially about 1.6 to 2.5% w/w of theactive in the composition.

It is known that alkoxy silyl quaternary ammonium compounds hydrolyze inwater forming the trihydroxy silicon functional group, therefore, forexample, 3-trimethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammoniumchloride is hydrolyzed to form as 3-trihydroxy silylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride. The alkyl silylammonium compounds are made in ethanol or methanol as a solvent. Thereis 22% methanol in1-octadecanaminium-N,N-dimethyl-N-[3-trimethoxysilyl(propyl)] chlorideproduct.

The addition of the polymer from 1-Octadecanaminimum-N,N-Dimethyl-N-[(3-trihydroxysilyl)propyl] chloride couples with themonomer forming high density sites upon drying (film forming) that arecloser to the surface than the monomeric condensation polymericreaction. The topography of the film formed becomes peaks and troughs.

An advancement in binding to substrates is incorporated with theaddition of 1,2-Bis(triethoxysilyl) ethane or1,2-Bis(Triethoxysilyl)methane having the following chemical structures:

From Doshi et al (Peering into the self assembly of surfactant templatedthin film silica mesophases) the novel formation of thin films isattainable as he states “It is now recognized that self-assembly is apowerful synthetic approach to the fabrication of nanostructures withfeature sizes smaller than achievable with state of the art lithographyand with a complexity approaching that of biological systems”. Doshistates “using time-resolved grazing incidence small-angle X-rayscattering (GISAXS) combined with gravimetric analysis and infraredspectroscopy, we structurally and compositionally characterized in situthe evaporation induced self-assembly of a homogeneoussilica/surfactant/solvent solution into a highly orderedsurfactant-templated mesostructure. Using CTAB (cetyltrimethylammoniumbromide) as the structure-directing surfactant, a two-dimensional (2-D)hexagonal thin-film mesophase (p6 mm) with cylinder axes orientedparallel to the substrate surface forms from an incipient lamellarmesophase through a correlated micellar intermediate. Comparison withthe corresponding CTAB/water/alcohol system (prepared without silica)shows that, for acidic conditions in which the siloxane condensationrate is minimized, the hydrophilic and nonvolatile silicic acidcomponents replace water maintaining a fluidlike state that avoidskinetic barriers to self-assembly.”

By maintaining neutral pH of 6-8 the formulation maximizes condensationpolymerization with the incorporation of the Bis(trimethoxysilyl)ethane.

The Polyhexanide salts for use in compositions according to theinvention will typically be the protonated form of the following generalformula;

wherein n may have a value of up to about 500 or more, but typically hasa value of 1-40, with termination of the polymer chain provided by anappropriate end group (see the Block reference described above). Inpreferred embodiments of the invention, n has an average value of 10-13;such a cosmetically acceptable Polyhexanide salt is the hydrochloridesalt, which can be commercially obtained from Lonza under the trade nameVantocil P. Preferably, the Polyhexanide can be present in compositionsaccording to the invention at a level of 0.01-0.5%, more preferably0.2-0.1% by weight of the composition, though good results have beenfound with a level of 0.1-0.5% by weight of Polyhexanide salts in thecomposition.

In some embodiments, the polymeric biguanide is a compound of formula:

wherein Z is absent or an organic divalent bridging group and each Z maybe the same or different throughout the polymer; n is at least 3,preferably 5 to 20 and X₃ and X₄ are independently selected from —NH₂,—NH—C(═NH)—NH—CN, optionally substituted alkyl, optionally substitutedcyclo alkyl, optionally substituted aryl, optionally substitutedheterocyclyl and optionally substituted heteroaryl; or apharmaceutically acceptable salt thereof. Preferably, the molecularweight of the polymeric compound is at least 1,000 amu, more preferablybetween 1,000 amu and 50,000 amu. In a single composition, n may varyproviding a mixture of polymeric biguanides.

The above polymeric biguanide compounds and methods for theirpreparation are described in, for example, U.S. Pat. No. 3,428,576 toEast et. al.

The preferred monomeric species is of the formula

The polymeric biguanide is present in the composition in an amount inthe range of 0.1% to 1.5% w/w, especially about 0.1% to about 1.0% w/w,more especially about 0.4% to about 0.6% w/w of the composition.

The polymeric biguanide is one of the most effective Pseudomonasaeruginosa biocides in water and active on biofilms of Pseudomonas. ThePolyhexanide acts as a viable biocide and also as a water-solublepreservative for extended shelf life.

In some embodiments a stabilizer for the polymeric system is added toprovide stearic hindrance to the reactive trimethoxysilyl ortrihydroxysilyl functional coupling groups. These stabilizer compoundsare found to be smectite clays, montmorillonite, kaolin or bentoniteclays, gums and sol gels. The water trapped within the clay matrix asshown in FIG. 1 provides for a water bridge at the trihydroxysilylstability and freeze point reduction.

In another aspect of the present invention, there is provided a suitableactive antimicrobial or biocide that is compatible with a carrier toprovide the bactericidal active. Benzalkonium chloride exists as amixture of N,N-dimethyl alkyl amine homologs having the followingstructure. The benzalkonium antimicrobial agent can have the followingstructure:

where n=8, 10, 12, 14, 16, 18.

Other quaternary ammonium salts that can be used correspond to theformula:

wherein R₁ is a benzyl group, R₂ is a C₂-C₂₂ alkyl group and R₃ and R₄are methyl groups. In one embodiment, the benzalkonium chloride is USPgrade, having not less than 40% C₁₂, not less than 20% C₁₄, and not lessthan 70% C₁₂ and C₁₄ homologs combined. In another embodiment, thecombination of C₁₂ and C₁₄ homologs is less than 90%, less than 85%,less than 80%, or less than 75% combined C₁₂ and C₁₄ homologs. In afurther embodiment, the homolog distribution is approximately 67% C₁₂,approximately 25% C₁₄, approximately 7% C₁₆ and approximately 1% C₁₈.

The benzalkonium chloride compound is present in an amount in the rangeof about 0.1% to 3.0% w/w of the composition, especially about 1.0% toabout 1.25% w/w, more especially about 1.0% to 1.1% w/w of thecomposition.

In another embodiment, the monomeric/polymeric carrier and activepossess a highly cationic charge or positive charge creating anelectromagnetic field or zeta potential that in water effectsmicroorganisms. Since microorganisms have a net negative charge oranionic charge. The combination of the two concentrations of cationiccharges and anionic charges allow for a coating of the bacteria and anagglomeration of resident bacteria on the skin into groupings ofbacteria that become encapsulated and osmotically and electrochemicalface cell lysis. This is extremely advantageous for Clostridiumdifficile spores contamination in hospital and adult care settings.

The present invention provides a secondary carrier system of the activeand film former polymer and monomer consisting of a surfactant systemwhich emulsifies any oil to form an oil in water emulsion and wets andtreats oil found on the surfaces during application. This invention doesclean surfaces. The surfactant package requires non-ionic or amphotericor zwitterionic systems comprising an alcohol ethoxylate, an alkylglucoside or alkyl polyglycoside an alcohol EO/PO(ethoxylated/propoxylated) and/or betaine.

In particular embodiments, the alcohol ethoxylate is an alkyl alcoholethoxylate, with HLB>9.0 for an oil in water emulsion. Biologicalactivity in emulsions is found especially with C₁₂-C₁₈ alcoholethoxylate and more especially a C₁₂₋₁₅ alcohol ethoxylate group. Inparticular embodiments, the alcohol ethoxylate comprises 6 to 16ethoxylate groups, especially about 10 to 14 ethoxylate groups. Anexample of a useful alcohol ethoxylates are Pareth-9 or Isodecyl alcoholEO/PO or Laureth 6 or Polyol 4290.

The alcohol ethoxylate is present in the composition in an amount in therange of 0.1% to 3.0% w/w, especially 0.2 to 2.5% w/w, more especiallyabout 0.25 to 2.0% w/w of the composition.

In particular embodiments, the alkylglucoside or alkylpolyglycoside is aC₈-C₁₈ alkylglucoside or alkylpolyglycoside, or a mixture thereof. Insome embodiments, the alkylglucoside or alkylpolyglycoside is selectedfrom caprylyl glucoside, caprylyl/capryl glucoside, octyl glucoside,decyl glucoside, dodecyl glucoside, coco glucoside, lauryl glucoside,caprylyl polyglycoside, caprylyl/capryl polyglycoside, decylpolyglycoside, dodecyl polyglycoside, coco polyglycoside stearylpolyglucoside, lauryl polyglycoside, pentaerythritol ethoxylate andisodecyl alcohl ethoxylate propo

The alkyl glucoside or alkylpolyglycoside is present in the compositionin an amount in the range of 0.1% to 0.5% w/w, especially about 0.2 to0.4% w/w of the composition.

In other embodiments, the composition may also include other optionalcomponents such as rheological modifiers, pH adjusters, lubricants,humectants, UV absorbers, fragrances and dyes. Suitable rheologicalmodifiers include smectite clays, hydroxyethyl cellulose, hydroxy-propylcellulose and Carbopol.

Suitable pH adjusters include buffers, acids and bases. For example, asuitable acidic adjuster is citric acid for pH control at 4-7 and asuitable alkaline adjuster is sodium hydroxide for pH control at 6-8.Other suitable acidic adjusters include benzoic acid, sorbic acid andlactic acid.

In the following examples, 15 formulations were made for testing as bothready to use and concentrates. Several of the formulations were testedin various laboratories around the world under AOAC and ASTM protocols.For Governmental approvals bacteria tested were E. coli, Staphylococcusaureus (including MRSA), Pseudomonas aeruginosa and Salmonella enterica.Some testing depicted in TABLE 4 included hard water at 200 ppm and 5%organic soil loadings at 92% dilutions of the products. All passed thetest requirements. The formulations were tested for Clostridiumdifficile spores with two formulations and killed log 4 in 10 minutes.

The formulations were incorporated on a Polyester wipe size 12×12 incheswith 30 ml of formulation on the wipe and passed over a glass plateinoculated with Clostridium difficile spores. The samples were allowedto air dry for 120 minutes and then sampled. The results showed a log1.44 kill on the surface. The used wipes were tested after a 24 hourperiod and showed a log 4.59 kill.

In several of the formulations chemical compounds which are known togerminate spores to include Bacillus and Clostridium were added in lowdosage. The dodecylamine would increase probability of germination whileencapsulated in the trialkyloxysilyl quaternaries. The dodecylaminepenetrates the spore coatings.

The following examples are intended to demonstrate the usefulness ofpreferred embodiments of the present invention and should not beconsidered to limit its scope or applicability in any way.

EXAMPLES Example 1

Formulations of My Shield Hospital Grade Disinfectant as a Ready to UseHard Surface Spray Disinfectant

TABLE 1 FORMULA FORMULA FORMULA FORMULA FORMULA NO-1, NO-2 NO-3 NO-4NO-5 CHEMICAL WT % WT % WT % WT % WT % DI WATER 93.54995 93.0489593.04995 93.04995 93.04895 ODTMSPC¹ 2.2 2.2 2.2 2.2 2.2 ODTHSPCP² — — —— 0.001 ODTESPC³ — — — — — BARDAC 208M 1.25 1.25 1.25 1.25 1.25 PHMBG⁴2.5 2.5 2.5 2.5 2.5 GELEST SIB 1817⁵ — 0.001 — — — GLUCAPON 225 0.25 0.5— — — PARETH 9 0.25 0.5 — — — TOMADOL 900 — — 1.0 — — TOMADOL 902 — 1.0EMUGEN HP16 — 1.0 POLYOL 4092 — EDTA NA 0.00005 0.00005 0.00005 0.000050.00005 CITRIC ACID buffer as needed ¹1-Octadecanaminium,N,N,Dimethyl-N-[(3-trimethoxysilyl) propyl] chloride = ODTMSPC²1-Octadecanaminium, N,N,Dimethyl-N-[(3-trihydroxysilyl) propyl]chloride polymer = ODTHSPCP ³1-Octadecanaminium,N,N,Dimethyl-N-[(3-triethoxysilyl) propyl] chloride = ODTESPC ⁴Polymericbiguanide HCL = PHMBG ⁵1,2-bis(triethoxysilyl)ethane

Several formulations were blended into DI water at 50-70 C with highshear mixing technology. Part A The addition of >2.2 wt % (>1.5 wt %active) 1-Octadecanaminium, N,N, Dimethyl-N-[(3-trimethoxysilyl) propyl]chloride (ODTMSPC) and 1-Octadecanaminium, N,N,Dimethyl-N-[(3-triethoxysilyl) propyl] chloride (ODTESPC) are added to50 C DI water with high shear mixing to dissolve and then requiresadditions of various surfactants for stable emulsions/dispersions. PartA was added to Part B with the components already in a mixed by aspecial reactor with side sweep agitation, circulation pump and highshear rotor stator agitator at 50 C. Ph has target range of 5.5-6.5.Adjust with citric acid. Compositions were subjected to quality inprocess analysis and microbial lab testing.

Example 2

Formulations of My Shield Hospital Grade Disinfectant as a Ready to UseHard Surface Spray Disinfectant

TABLE 2 FORMULA FORMULA FORMULA FORMULA FORMULA NO-1, NO-2 NO-3 NO-4NO-5 CHEMICAL WT % WT % WT % WT % WT % DI WATER 92.0495 92.0485 92.048592.0495 94.5485 ODTMSPC¹ 2.2 2.2 — — 2.2 ODTHSPCP² — — — — ODTESPC³ — —2.2 — — DDTMSPC⁵ — 0.001 0.001 2.2 0.001 BARDAC 208M 1.25 1.25 1.25 1.251.25 PHMBG⁴ 2.5 2.5 2.5 2.5 — EMULGEN HP16 2.0 2.0 2.0 2.0 2.0 EDTA NA0.0005 0.0005 0.0005 0.0005 0.0005 CITRIC ACID buffer as needed¹1-Octadecanaminium, N,N,Dimethyl-N-[(3-trimethoxysilyl) propyl]chloride = ODTMSPC ²1-Octadecanaminium,N,N,Dimethyl-N-[(3-trihydroxysilyl) propyl] chloride polymer = ODTHSPCP³1-Octadecanaminium, N,N,Dimethyl-N-[(3-triethoxysilyl) propyl] chloride= ODTESPC ⁴Polymeric biguanide HCL = PHMBG ⁵1-Dodecanaminium, N,NDimethyl-N-[(3-trimethoxylsilyl) propyl] chloride = DDTMSPC

Several formulations were blended into DI water at 50-70 C with highshear mixing technology. Part A The addition of >2.2 wt % (>1.5 wt %active) 1-Octadecanaminium, N,N, Dimethyl-N-[(3-trimethoxysilyl) propyl]chloride (ODTMSPC) and 1-Octadecanaminium, N,N,Dimethyl-N-[(3-triethoxysilyl) propyl] chloride (ODTESPC) are added to50 C DI water with high shear mixing to dissolve and then requiresadditions of various surfactants for stable emulsions/dispersions. PartA was added to Part B with the components already in a mixed by aspecial reactor with side sweep agitation, circulation pump and highshear rotor stator agitator at 50 C. pH has target range of 5.5-6.5.Adjust with citric acid. Compositions were subjected to quality inprocess analysis and microbial laboratory testing.

Example 3

Formulations of My Shield Hospital Grade Disinfectant 3× Concentrate

TABLE 3 Formula Formula Formula Formula Formula No. 1, No. 2 No. 3 No. 4No. 5 CHEMICAL Wt % Wt % Wt % Wt % Wt % DI Water  76.145 76.144  80.394 79.145  79.394 ODTMSPC¹ 6.6 6.6 6.6 6.6 — ODTHSPCP² — — — ODTESPC³ — —6.6 DDTMSPC⁵ — — — ADBAC — 3.0 — — BARDAC 208M  3.75 3.75 —  3.75 3.5PHMBG⁴ 7.5 7.5 7.5 7.5 7.5 EMULGEN HP16 6.0 6.0 — — — POLYOL 4290 — —3.0 3.0 TOMADLOL 900 — — — — GLUCAPON 425 — 1.0 — — TOMADOL 25-12 1.5 —— TRIETHANOLAMINE 0.001  0.001 — — EDTA N A  0.005 0.005  0.005  0.005 0.005 LAURAMINE  0.001 ¹1-Octadecanaminium,N,N,Dimethyl-N-[(3-trimethoxysilyl) propyl] chloride = ODTMSPC²1-Octadecanaminium, N,N,Dimethyl-N-[(3-trihydroxysilyl) propyl]chloride polymer = ODTHSPCP ³1-Octadecanaminium,N,N,Dimethyl-N-[(3-triethoxysilyl) propyl] chloride = ODTESPC ⁴Polymericbiguanide HCL = PHMBG ⁵1-Dodecanaminium, N,NDimethyl-N-[(3-trimethoxylsilyl) propyl] chloride = DDTMSPC

Several formulations were blended into DI water at 50-70 C with highshear mixing technology. Part A The addition of >2.2 wt % (>1.5 wt %active) 1-Octadecanaminium, N,N, Dimethyl-N-[(3-trimethoxysilyl) propyl]chloride (ODTMSPC) and 1-Octadecanaminium, N,N,Dimethyl-N-[(3-triethoxysilyl) propyl] chloride (ODTESPC) are added to50 C DI water with high shear mixing to dissolve and then requiresadditions of various surfactants for stable emulsions/dispersions. PartA was added to Part B with the components already in a mixed by aspecial reactor with side sweep agitation, circulation pump and highshear rotor stator agitator at 50 C. pH has target range of 6.0-7.0.Adjust with triethanolamine or lauramine. Compositions were subjected toquality in process analysis and microbial laboratory testing.

Example 4

My Shield Hospital Grade Disinfectant 3× Concentrate Formula 1 Table 3Diluted 3:1 in DI Water

Technical Standard for Disinfection (2002 Ministry of Health P.R.China)-2.1.1.7.4 Suspension Quantitative Germicidal Test by GuangdongDetection Center of Microbiology,

TABLE 4 CFU of CFU in Sample Test bacteria CFU Average test and timeTested organism number control in control sample Log kill Kill rate %My-shield E coli 1 3.0 × 10⁷ 3.3 × 10⁷ <10 ≥5.00 >99.999 Formula ATCC8099 Ex 1 E coli 2 3.3 × 10⁷ <10 ≥5.00 >99.999 At 10 min ATCC 8099 Ecoli 3 3.5 × 10⁷ <10 ≥5.00 >99.999 ATCC 8099 My shield Staphylococcus 14.2 × 10⁷ 4.2 × 10⁷ <10 ≥5.00 >99.999 Formula aureus ATCC of Ex 1 6538At 10 min Staphylococcus 2 3.9 × 10⁷ <10 ≥5.00 >99.999 aureus ATCC 6538Staphylococcus 3 4.5 × 10⁷ <10 ≥5.00 >99.999 aureus ATCC 6538 My shieldPseudomonas 1 1.2 × 10⁷ 1.3 × 10⁷ <10 ≥5.00 >99.999 Formula aeruginosaof Ex 1 ATCC 15442 At 10 min Pseudomonas 2 1.4 × 10⁷ <10 ≥5.00 >99.999aeruginosa ATCC 15442 Pseudomonas 3 1.2 × 10⁷ <10 ≥5.00 >99.999aeruginosa ATCC 15442

Example 5

Aoac 961.0 Germicidal Spray Product as Disinfectants Test Using FormulaNo 1 on Table 2 My Shield Hospital Grade Disinfectant 3× Concentrate

The Quality Assurance Unit has inspected the project no 1514-021418ESClab #129873-129875 in compliance with 40 CFR Part 160. Accugen Labs Inc

TABLE 5 A: Disinfectant Efficacy Test Results Against StaphylococcusAureus at 200 Ppm

Hard Water, 5% Organic Soil Load and at 92.0% Activity

TABLE 5A # OF # OF SAMPLE EXPOSURE TREATED GROWING GROWTH ID LOT#ORGANISM TIME MIN CARRIERS CARRIERS RESULTS 01187940 S AUREUS 10 60 0101/60 ATTC 6538 MINUTES 01187941 S AUREUS 10 60 01 01/60 ATTC 6538MINUTES 01187942 S AUREUS 10 60 0 00/60 ATTC 6538 MINUTESTable 5 B: Disinfectant Efficacy Test Results Against SalmonellaEnterica at 200 PpmHard Water, 5% Organic Soil Load and at 92.0% Activity

TABLE 5B # OF # OF SAMPLE EXPOSURE TREATED GROWING GROWTH ID LOT#ORGANISM TIME MIN CARRIERS CARRIERS RESULTS 01187940 S ENTERICA 10 60 00/60 ATCC 10708 MINUTES 01187941 S ENTERICA 10 60 0 0/60 ATCC 10708MINUTES 01187942 S ENTERICA 10 60 0 0/60 ATCC 10708 MINUTESTable 5c: Disinfectant Efficacy Test Results Against PseudomonasAerguinosaat 200 PpmHard Water, 5% Organic Soil Load and at 92.0% Activity

TABLE 5C # OF # OF SAMPLE EXPOSURE TREATED GROWING GROWTH ID LOT#ORGANISM TIME MIN CARRIERS CARRIERS RESULTS 01187940 P AERUGINOSA 10 600 0/60 ATCC 15442 MINUTES 01187941 P AERUGINOSA 10 60 0 0/60 ATCC 15442MINUTES 01187942 P AERUGINOSA 10 60 0 0/60 ATCC 15442 MINUTES

Example 6

Clostridium Difficle Spores—Standard Quantitative Disk Carrier TestMethod Astm E 2197 Formulation From Table 3 Number 2

TABLE 6 GEOMETRIC MEAN GEOMETRIC MEAN SURVIVORS OF SURVIVORS OF #SURVIVORS/ TEST CARRIERS CONTROL CARRIERS TEST CARRIER TEST CARRIER(AVERAGE LOG₁₀ (AVERAGE LOG₁₀ % REDUCTION ORGANISM # (LOG₁₀) OF TESTCARRIERS) OF TEST CARRIERS) (LOG₁₀ REDUCTION) C. DIFFICLE 1 >2.00 ×10² >2.00 × 10² 2.45 × 10⁶ 99.9918% SPORE FORM (>2.30) (>2.30) (6.39)(4.09) ATCC 43598 2 >2.00 × 10² (>2.30) 3 >2.00 × 10² (>2.30) 4 >2.00 ×10² (>2.30) 5 >2.00 × 10² (>2.30)

Example 7

Custom Sporicidal Efficacy Testing¹ on Clostridium Difficle with MyShield Hospital Grade Disinfectant Formulation Table 1 Formulation No 5

TABLE 7 Test Article Avg Cfu And Contact Per Avg % Log Test OrganismCarrier Time Replicate Cfu/Carrier Carrier Log Red Red C DIFFICLECONTROL TIME 1 3.55 × 10⁵ 3.88 × 10⁵ 5.59 NA ENDOSPORES ON GLASS ZERO 23.45 × 10⁵ ATCC 43598 CARRIER 3 4.65 × 10⁵ MY 2 1 4.00 × 10⁴ 1.42 × 10⁴4.15 96.4 1.44 SHIELD HOURS 2 1.30 × 10³ ON GLASS 3 1.30 × 10³ CARRIERMY 24 1 <1.0 × 10¹ <1.00 × 10¹  <1.0 99.99 >4.59 SHIELD HOURS 2 <1.0 ×10¹ ON WIPE 3 <1.0 × 10¹ RECOVERY 1. Vivo Clinical Testing, Austin Texas

Example 8

Astm E2839-11 Protocol for Sporicidal Efficacy Testing of ClostridiumDifficle with My Shield Hospital Grade Disinfectant Formulation Table 3Formulation No 3

TABLE 8 Average Average Test Carrier # Survivors/Carrier Surviors OfSurvivors Of % Reduction Organism # (Log₁₀) Test Carriers ControlCarriers (Log Reduction) CLOSTRIDIUM 1 >2.00 × 10² >2.00 × 10² 2.45 ×10⁶ 99.9918 DIFFICILE (>2.30) (>2.30) (6.39) (4.09) SPORE FORM 2 >2.00 ×10² ATCC 43598 (>2.30) 3 >2.00 × 10² (>2.30) 4 >2.00 × 10² (>2.30)5 >2.00 × 10² (>2.30)

Example 10

My Shield Hospital Grade Disinfectant 3× Concentrate Formula 1 Table 3Diluted 4:1 in DI Water Renamed My Shield Mold and Mildew Disinfectant

Technical Standard For Disinfection (2002 Ministry Of Health P.R.China)-2.1.1.7.4 Suspension Quantitative Germicidal Test By GuangdongDetection Center Of Microbiology,

TABLE 10 CFU of CFU in Sample Tested Test bacteria CFU Average test Killand time organism number control in control sample Log kill rate %My-shield E coli 1 3.0 × 10⁷ 3.3 × 10⁷ <10 ≥5.00 >99.999 Formula ATCC8099 Ex 1 E coli 2 3.3 × 10⁷ <10 ≥5.00 >99.999 At 10 min ATCC 8099 Ecoli 3 3.5 × 10⁷ <10 ≥5.00 >99.999 ATCC 8099 My shield Staphylococcus 14.2 × 10⁷ 4.2 × 10⁷ <10 ≥5.00 >99.999 Formula aureus ATCC of Ex 1 6538At 10 min Staphylococcus 2 3.9 × 10⁷ <10 ≥5.00 >99.999 aureus ATCC 6538Staphylococcus 3 4.5 × 10⁷ <10 ≥5.00 >99.999 aureus ATCC 6538 My shieldPseudomonas 1 1.2 × 10⁷ 1.3 × 10⁷ <10 ≥5.00 >99.999 Formula aeruginosaof Ex 1 ATCC 15442 At 10 min Pseudomonas 2 1.4 × 10⁷ <10 ≥5.00 >99.999aeruginosa ATCC 15442 Pseudomonas 3 1.2 × 10⁷ <10 ≥5.00 >99.999aeruginosa ATCC 15442

The contents of all references cited in the instant specifications andall cited references in each of those references are incorporated intheir entirety by reference herein as if those references were denotedin the text

While the many embodiments of the invention have been disclosed aboveand include presently preferred embodiments, many other embodiments andvariations are possible within the scope of the present disclosure andin the appended claims that follow. Accordingly, the details of thepreferred embodiments and examples provided are not to be construed aslimiting. It is to be understood that the terms used herein are merelydescriptive rather than limiting and that various changes, numerousequivalents may be made without departing from the spirit or scope ofthe claimed invention.

What is claimed is:
 1. A composition for inducing and inflicting damage to cell membranes of infectious microorganism by inducing changes in membrane permeability, said composition comprising effective amounts of an alkoxy silyl quaternary ammonium polymer and an alkoxy silyl quaternary ammonium film forming agent; an antimicrobial and antiviral polymeric macromolecule having the formula

Wherein n is about 500 or more; an antimicrobial molecule; one or more surfactants for micellar dispersions and self assembly properties; a chelating agent, a preservative and optionally a fragrance; and wherein said antimicrobial molecule is selected from the group consisting of: Benzalkonium chloride, 32% Alkyl (C₁₄ 50%, C₁₂ 40%, C₁₆ 10%,) Dimethyl benzyl ammonium chloride, Octyldecyl dimethyl ammonium chloride, Dioctyl dimethyl ammonium chloride, Didecyl dimethyl ammonium chloride and mixtures thereof dissolved in a solvent containing 10% ethyl alcohol and 10% Water.
 2. The composition of claim 1, wherein said an alkoxy silyl quaternary ammonium film forming agent is selected from the group consisting of: 1-Octadecanaminium, N, N-dimethyl-N-[(3-trimethoxysilyl)propyl] chloride; 1-Octadecanaminium, N, N-dimethyl-N-[(3-trihydroxysilyl) propyl] chloride polymer; 1-Octadecanaminium, N, N-dimethyl-N-[(3-triethoxysilyl)propyl] chloride and mixtures thereof.
 3. The composition of claim 1, further comprising a coupling agent selected from the group consisting of: 1,2-Bis(triethoxysilyl) ethane and 1,2-Bis(Triethoxysilyl)methane and mixtures thereof.
 4. The composition of claim 1, wherein said alkoxy silyl quaternary ammonium polymer film forming agent includes Trihydroxysilyl propyl dimethyl octadecyl ammonium polymer and mixtures thereof.
 5. The composition of claim 1, wherein said surfactants are selected from the group consisting of: non-ionic surfactants, amphoteric surfactants, zwitterionic surfactants, anionic surfactants and mixtures thereof.
 6. The composition of claim 1, wherein said chelating agent is selected from the group consisting of: ethylenediamine-N,N,N′,N′-tetraacetic acid (EDTA); monosodium, disodium, trisodium, tetrasodium, dipotassium, tripotassium, dilithium and diammonium salts of EDTA; barium, calcium, cobalt, copper, dysprosium, europium, iron, indium, lanthanum, magnesium, manganese, nickel, samarium, strontium, and zinc chelates of EDTA; trans-1,2-diaminocyclohexane-N,N,N′,N′-tetra-acetic acid monohydrate; N,N-bis(2-hydroxyethyl)glycine; 1,3-diamino-2-hydroxy-propane-N,N,N′,N′-tetra-acetic acid; 1,3-diamino-propane-N,N,N′,N′-tetraacetic acid; ethylene-diamine-N,N′-diacetic acid; ethylenediamine-N,N′-dipropionic acid dihydrochloride; ethylene-diamine-N,N′-bis(methylene-phosphonic acid) hemihydrate; N-(2-hydroxyethyl)ethylenediamine-N,N′,N′-triacetic acid; ethylenediamine-N,N,N′,N′-tetrakis-(methylenephosponic acid); 0,0′-bis(2-aminoethyl)-ethylene-glycol-N,N, N′,N′-tetraacetic acid; N,N-bis(2-hydroxybenzyl)ethylene di-amine-N,N-diacetic acid; 1,6-hexa-methylenediamine-N,N,N′,N′-tetraacetic acid; N-(2-hydroxy-ethyl)iminodiacetic acid; imino-diacetic acid; 1,2-di aminopropane-N,N,N′,N′-tetraacetic acid; nitrilotriacetic acid; nitrilo-tripropionic acid; the trisodium salt of nitrilotris(methylenephosphoric acid); 7,19,30-trioxa-1,4, 10,13,16,22,27,33-octaazabicyclo [11,11,11]pentatriacontane hexahydrobromide; triethylene-tetramine-N,N,N′,N″, N″′,N″″-hexaacetic acid; deferoxamine; deferiprone; and deferasirox.
 7. The composition of claim 1, for use as a bacteriostatic on hard surfaces and on porous surfaces.
 8. The composition of claim 1, for use as a hard surface disinfectant.
 9. The composition of claim 1, for use as a cleaning sanitizer.
 10. The composition of claim 1, for use as a hospital grade disinfectant against viruses, fungi, mold and bacteria.
 11. The composition of claim 1, for use against MRSA.
 12. The composition of claim 1, for use in killing spores.
 13. The composition in claim 1, which attacks microorganisms by polycation adhesion and coats Clostridium difficile spores instantly, agglomerates spore bodies and renders cellular necrosis in 10 minutes.
 14. The composition of claim 1, wherein said composition dries on surfaces in a minute and via condensation polymerization by water evaporation and by heat forms a polymeric coating.
 15. The composition of claim 2, wherein said trialkoxy functional groups from the 1-Octadecanaminium-N,N-dimethyl-N-[3-trimethoxysilyi) propyl] chloride adhere to surfaces and cellular membranes.
 16. The composition of claim 3, wherein said composition exhibits adhesion to a substrate.
 17. The composition of claim 1, for use in killing bacteria protected by bio films. 